MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Date of event ¿ unknown date in (b)(6) of 2016.Date explanted ¿ unknown date in (b)(6) of 2016.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

Event Description

Patient underwent a shoulder revision approximately seven years post-implantation due to a fractured taper.The humeral tray and humeral bearing were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6060115
• MDR Text Key: 58499847
• Report Number: 0001825034-2016-04285
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 848110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR